DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-22) in the reply filed on 4/29/26 is acknowledged.
Claim Objections
Claim 5 is objected to because of the following informalities: line 1-2 should be amended to - wherein the torque limiting actuator limits the torque applied to the [[actuator]] torquer in a first direction but does not limit the torque-. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: line 3 should be amended to -perpendicular to a longitudinal axis of [[a]] the torquer to pinch the EMD-. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: line 3 should be amended to - a biasing member biasing the drive gear into engagement with a driven gear secured to the shaft.-. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 16:
The claim limitations “an actuator movable relative to the body…” and “a knob releasably connected to the actuator…” in lines 7-11 are unclear. The claim indicates these are part of the torquer but theses structures are part of the torque limiting actuator (¶0011 in the specification indicates this). This which raises a question of if these are part of the torquer and the torque limiting actuator is a separate additional structure or if the structure of the torquer and the torque limiting actuator are found in the claim. For the sake of examination, the office has assumed that the actuator and knob are part of the torque limiting actuator. However, the applicant should amend the claim to clarify.
Regarding claim 17:
The claim recites the limitation "the drive module" in the final line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claims 18-22 are rejected due to their dependence on claim 17.
Regarding claim 22:
The claim limitation “a torque limiting actuator” in line 2 is unclear. The limitation is unclear because of the earlier recitation of the limitation “a torque limiting actuator” in line 6 of claim 17 (on which this claim depends) which raises a question of if two of torque limiting actuators are required by the claim 22 or only one. For the sake of examination, the office has assumed that only one torque limiting actuator is required by the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20090270890 A1 to Robinson et al. (Robinson).
Robinson discloses:
Regarding claim 1:
A device (134) for manipulating an elongated medical device (136) comprising:
a torquer (144/146) releasably securing an elongated medical device (EMD) (136) thereto;and
a torque limiting actuator (154) limiting a torque applied to the torquer (¶0039, 0042).
Regarding claim 2:
The device of claim 1, wherein the torque limiting actuator (154) limits the torque applied to the torquer (144/146) to a predetermined torque (¶0042).
Regarding claim 3:
The device of claim 1, wherein the torque limiting actuator (154) includes a manual operator (138 or user rotating handle 138) and a clutch (156/158) that prevents an application of torque to the torquer (144/146) beyond a predetermined torque (¶0042).
Regarding claim 4:
The device of claim 1, wherein the torque limiting actuator (154) includes a knob (138) being manually rotated about a longitudinal axis (as shown in figures 5 and 7) of the torquer (144/146), a biasing member (168) between a portion of the knob (138) and a first clutch member (158)(see line A in figure 1 below which shows the biasing member 168 is arranged between knob 138 and first clutch member 158), wherein the first clutch member (158) imparts torque to a second clutch member (156) until a predetermined torque between the first clutch member and second clutch member is reached (¶0042).
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Figure 1 – figure 6 of Robinson, annotated by the examiner
Regarding claim 5:
The device of claim 1, wherein the torque limiting actuator (154) limits the torque applied to the actuator (as indicated above this has been interpreted to refer to the torquer) in a first direction but does not limit the torque applied to the actuator in a second opposite direction (¶0017 indicates the torque limiting actuator 154 can apply torque in one direction for a first embodiment or two different directions for another embodiment).
Regarding claim 6:
The device of claim 1, wherein the torquer (144/146) includes a torquer body (146/150) and a pusher (see pusher B in figure 1 above) movable within the torquer body to move at least a first pad (see the pad C in figure 1 above) in a direction perpendicular to a longitudinal axis (clamps inward to the shaft 136) of a torquer (144/140) to pinch the EMD (136).
Regarding claim 7:
The device of claim 1, wherein a pinch force (force exerted by 140 on the shaft 136) perpendicular to a longitudinal axis of the torquer (144/146) between the torquer and the EMD (136) is a function of the torque applied by the torque limiting actuator (154/146) to the torquer (the application of torque from 140 to the shaft 146 results in the pinch force of C/146 as shown in figure 1 above).
Regarding claim 8:
The device of claim 3, wherein the clutch (156/158) is a spring biased first gear (156 with teeth 160) that engages a second gear (158 with teeth similar to 160).
Regarding claim 9:
The device of claim 8, wherein the spring biased first gear (156 with teeth 160) slips relative to the second gear (158 with teeth similar to 160) once a predetermined torque (¶0042) between the first gear (156 with teeth 160) and the second gear (158 with teeth similar to 160) is exceeded (as indicated in ¶0042).
Regarding claim 10:
The device of claim 6, wherein the torquer (144/146) includes a second pad (other pad of the clamp on the opposite side of C as shown in figure 1 above) spaced from and movable toward and away from the first pad (C as indicated in figure 1 above consists of 2 to 4 pads that clamp around shaft 136) to releasably pinch the EMD (136).
Regarding claim 11:
The device of claim 10, further including a biasing member (168) having a pair of arms (see the arms/ends D and E of the spring 168 in figure 1 above) spaced from one another and spaced from a longitudinal axis (as shown in figure 1 above) of the torquer (144/140).
Regarding claim 12:
The device of claim 1, wherein the torque limiting actuator (154) includes a shaft (140) having a portion (152) threadedly secured to a body (146) of the torquer (144/146) and a distal portion (see chamfered end F in figure 1 above) operatively moving a pad (pad C in figure 1 above) into engagement with the EMD (136) upon rotation of the shaft (140) relative to the body (146) (rotating 140 relative to 146 cause the threads 152/150 to push the portion C against F in figure 1 above and clamp C to 136).
Regarding claim 13:
The device of claim 12, wherein the torque limiting actuator (154) includes a drive gear (156) and a biasing member (168) biasing the drive gear into engagement with (spring 168 applies a force to 156 into engagement with 156) a driven gear (158) secured to (158 secured to the shaft 140 via handle 138) the shaft (140), the drive gear.
Regarding claim 14:
The device of claim 13, wherein the torque limiting actuator (154) includes a knob (138) manually rotated relative to (can spin relative to the body 146 when the members 156/158 slip relative to each other) the body (146), the knob being releasably connected to the shaft (140) upon an application of a predetermined torque (the members 156/158 slip relative to each other based on the application of torque as indicated in ¶0042 which indicates knob 138 is rotationally released from shaft 140 based on the torque applied).
Regarding claim 15:
The device of claim 1, wherein the torque limiting actuator (154) provides an indication (the handle 154 slips due to 158 and 156 when the maximum torque is reached as indicated in ¶0042) to a user once adequate torque has been applied to the torquer (144/140).
Regarding claim 16:
The device of claim 1, wherein the torquer comprises:
a body (140) having a cavity (148) defining a pathway (as shown in figure 6);
a first pad (C in figure 1 above) movable within the cavity (148);
a biasing member (B as shown in figure 1 above where the first pad is actuated by the spring portion B of 146) separate from the first pad (C in figure 1 above) biasing the first pad (C in figure 1 above) relative to the body (140);
an actuator (156/158) movable relative to the body (140) moving the first pad (C in figure 1 above), wherein movement of the first pad (C in figure 1 above) pinches and/or unpinches (C in figure 1 above clamps the EMD 136) the elongated medical device (136), with the first pad (C in figure 1 above), within the pathway; and
a knob (138) releasably connected to the actuator (156/158) upon an application of a predetermined torque exceeding a predetermined value (as the torque exceeds a maximum amount the knob 138 slip relative to the actuator portion 156 as indicated in ¶0046).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 17-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2021011551 A1 to Clark et al. (Clark) in view of US 20090270890 A1 to Robinson et al. (Robinson).
Regarding claim 17:
Clark discloses:
An EMD drive system (figure 37/38) comprising:
a robotic drive (361) having a robotic drive longitudinal axis (¶0118);
a device module (392) movable along the robotic drive longitudinal axis; and
a drive train (327 as shown in figure 25 or 49) coupling a motor to a driven member (a bevel gear connected to 327 or 504 as indicated in ¶0123) configured to rotate a torquer (326) about an elongated medical device (EMD) (324) about an EMD longitudinal axis (axis of 324), the torquer manually accessible to a user when the torquer is in an in-use position in the drive module (as shown in figure 25).
Clark fails to disclose:
a torquer pinching an elongated medical device (EMD) about an EMD longitudinal axis, the torquer including a torque limiting actuator being manually accessible to a user when the torquer is in an in-use position in the drive module
Robinson teaches:
A device (134) for manipulating an elongated medical device (136) comprising:
a torquer (144/146) releasably securing an elongated medical device (EMD) (136) thereto;and
a torque limiting actuator (154) limiting a torque applied to the torquer (¶0039, 0042).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Clark to further include replacing the torquer in Clark with the torquer with a torque limiting actuator connected to the EMD drive system of Robinson. This would include replacing to torquer and adding the torque limiting actuator connected to the drive train in Clark. This is a simple substitution of one known element (torquer in Clark) for another (torquer and torque limiting actuator in Robinson) to obtain predictable results (to apply a torque to an EMD).
Regarding claim 18:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 17 by Clark and Robinson:
The EMD drive system of claim 17, wherein the torque limiting actuator (154 of Robinson incorporated into Clark) limits the torque (144/146 of Robinson incorporated into Clark) applied to the torquer to a predetermined torque (¶0042 of Robinson).
Regarding claim 19:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 17 by Clark and Robinson:
The EMD drive system of claim 17, wherein the torque limiting actuator includes a manual operator (138 or user rotating handle 138 of Robinson incorporated into Clark) and a clutch (156/158 of Robinson incorporated into Clark) that prevents an application of torque to the torquer beyond a predetermined torque (¶0042 of Robinson).
Regarding claim 20:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 17 by Clark and Robinson:
The EMD drive system of claim 17, wherein the torque limiting actuator includes a knob (138 of Robinson incorporated into Clark) being manually rotated about a longitudinal axis (can spin relative to the body 146 when the members 156/158 slip relative to each other) of the torquer (146 of Robinson incorporated into Clark), a biasing member between a portion of the knob and a first clutch member (15 of Robinson incorporated into Clark 8)(see line A in figure 1 below which shows the biasing member 168 is arranged between knob 138 and first clutch member 158 of Robinson incorporated into Clark), wherein the first clutch member (158) imparts torque to a second clutch member (156 of Robinson incorporated into Clark) until a predetermined torque between the first clutch member and second clutch member is reached (¶0042 of Robinson incorporated into Clark).
Regarding claim 21:
Clark discloses:
The EMD drive system of claim 17, wherein the torquer (326) may be moved from a first device module (G in figure 2 below) to a second device module (H in figure 2 below).
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Figure 2 – figure 37 of Clark, annotated by the examiner
Regarding claim 22:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 17 by Clark and Robinson:
The EMD drive system of claim 17, wherein the torquer (326 of Clark) includes a torque limiting actuator (154 of Robinson incorporated into Clark) that limits the torque applied to the drive train beyond a predetermined torque(¶0042 of Robinson).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following is pertinent prior art:
US-20080039823-A1
Shimogami
See the torquer 2 and torque limiting actuator 3
US-20210196251-A1
Dull
See the torquer 124
US-20060282150-A1
Olson
See the torquer 52
WO-2017209695-A1
PENNY
See the torquer 320
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WESLEY G HARRIS/Examiner, Art Unit 3783
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